Product Development PortfolioLast update: Jul. 22, 2021

Therapeutic Area
Partner
Managed By
Compound/
Generic name
Trade name
Indication
Phase
123f
Expected Filing

1. Oncology

1. Oncology
CHU CD137 agonist switch antibody
solid tumors
4. Phase 1

Description/Summary:

Managed By:
3. Chugai
Roche Only
1. Oncology
CHU codrituzumab
Hepatocellular carcinoma
4. Phase 1

Description/Summary:

Managed By:
3. Chugai
Partner:
Chugai
1. Oncology
RG6007 HLA-A2-WT1 X CD3
Adult acute myeloid leukemia
4. Phase 1

Description/Summary:

RG6007 (HLA-A2-WT1 x CD3) is a T cell receptor (TCR)-like T-cell bispecific antibody targeting the HLA-A2-WT1 complex on tumor cells and CD3 on T-cells.

Managed By:
2. Pharma Research and Early Development
Roche Only
1. Oncology
RG6026 Glofitamab
relapsed or refractory non-Hodgkin's lymphoma
4. Phase 1

Description/Summary:

Glofitamab (Anti-CD20 CD3 TCB, RG6026) is a 2:1 format T cell-engaging bispecific antibody, designed to engage both CD20 on B cells and CD3 on T cells. By engaging both targets simultaneously, the antibody activates the T cells to attack and eliminate the B cells, allowing treatment of B cell cancers such as non-Hodgkin’s lymphoma. A phase I clinical trial is evaluating RG6026 for the treatment of relapsed or refractory non-Hodgkin's lymphoma.

Managed By:
2. Pharma Research and Early Development
Roche Only
1. Oncology
RG6026-2 Glofitamab
3L+ Diffuse Large B-Cell Lymphoma
4. Phase 1
2022

Description/Summary:

Glofitamab (Anti-CD20 CD3 TCB, RG6026) is a 2:1 format T cell-engaging bispecific antibody, designed to engage both CD20 on B cells and CD3 on T cells. By engaging both targets simultaneously, the antibody activates the T cells to attack and eliminate the B cells, allowing treatment of B cell cancers such as non-Hodgkin’s lymphoma.

Managed By:
2. Pharma Research and Early Development
Roche Only
1. Oncology
RG6058 tiragolumab
Heme and solid tumors combinations
4. Phase 1

Description/Summary:

tiragolumab (anti-TIGIT, RG6058) is a fully human monoclonal antibody designed to bind to TIGIT and prevent its interaction with poliovirus receptor (PVR). T cell immunoglobulin and ITIM domain protein (TIGIT), a member of the immunoglobulin superfamily, is a novel immune inhibitory receptor. A phase I clinical trial is evaluating tiragolumab in combination with Tecentriq for the treatment of solid tumors.

Managed By:
1. Roche Group
Roche Only
1. Oncology
RG6076 CD19-4-1BBL
heme tumours
4. Phase 1

Description/Summary:

CD19-4-1BBL(RG6076) is a fusion protein targeting the 4-1BB ligand to cells bearing CD19 acting as an NK- and T-cell co-stimulator.

Managed By:
2. Pharma Research and Early Development
Roche Only
1. Oncology
RG6115 TLR7 agonist (4)
Hepatocellular carcinoma
4. Phase 1

Description/Summary:

TLR7 agonist (4) is an oral, small molecule immuno-modulator activating the TLR (toll-like receptor) 7. It stimulates the production of cytokines and may promote an inflammatory microenvironment, fostering T-cell activation and anti-tumor immunity.

Managed By:
2. Pharma Research and Early Development
Roche Only
1. Oncology
RG6160 cevostamab
relapsed or refractory multiple myeloma
4. Phase 1

Description/Summary:

cevostamab (FcRH5 X CD3)

Managed By:
4. Genentech Research and Early Development
Roche Only
1. Oncology
RG6171 giredestrant
ER-positive and HER2-negative metastatic breast cancer
4. Phase 1

Description/Summary:

RG6171 (GDC-9545) is a selective estrogen receptor degrader (SERD) that is designed to bind to the estrogen receptor to limit its function. In addition, when SERDs bind to the estrogen receptor, they may be able to change the shape of the receptor in such a way that the cell eliminates it by degradation. A phase I clinical trial is evaluating RG6171 for the treatment of ER-positive and HER2-negative metastatic breast cancer.

Managed By:
4. Genentech Research and Early Development
Roche Only
1. Oncology
RG6180 autogene cevumeran
solid tumors
4. Phase 1
2024+

Description/Summary:

autogene cevumeran (Individualized Neoantigen-Specific Therapy, iNeST (RG6180) is a messenger RNA (mRNA)-based, individually tailored, personalized cancer vaccine. Each vaccine will be made using unique neoantigen signatures from an individual patient’s tumor, which is expected to elicit an effective immune response against that patient’s tumor. A phase I clinical trial is evaluating iNeST for the treatment of solid tumors.

Managed By:
4. Genentech Research and Early Development
Partner:
BioNTech AG
1. Oncology
RG6185 belvarafenib
solid tumors
4. Phase 1

Description/Summary:

belvarafenib (RG6185, GDC-5573, HM95573) is a selective small-molecule inhibitor of the RAF family kinases designed to inhibit the MAPK pathway, which is frequently activated in human tumors and drives tumor growth. A phase I clinical trial is evaluating RG6185 for the treatment of solid tumors.

Managed By:
4. Genentech Research and Early Development
Partner:
Hanmi Pharmaceutical
1. Oncology
RG6189 FAP-CD40
Solid tumors
4. Phase 1

Description/Summary:

Managed By:
2. Pharma Research and Early Development
Roche Only
1. Oncology
RG6194 HER2 X CD3
metastatic HER2-positive cancers
4. Phase 1

Description/Summary:

RG6194 is a bispecific antibody designed to target both the HER2-positive cells and CD3 on T cells. This dual-targeting antibody is designed to induce a polyclonal T-cell response against HER2-positive tumors. A phase I clinical trial is evaluating RG6194 for the treatment of metastatic HER2-positive cancers.

Managed By:
4. Genentech Research and Early Development
Roche Only
1. Oncology
RG6232 TYRP1 X CD3
metastatic melanoma
4. Phase 1

Description/Summary:

RG6232 (TYRP1 x CD3) is a T-cell bispecific antibody targeting the tyrosinase-related protein 1 (TYRP1) expressed on melanoma cells and CD3 on T-cells.

Managed By:
2. Pharma Research and Early Development
Roche Only
1. Oncology
RG6234 NME
multiple myeloma
4. Phase 1

Description/Summary:

Managed By:
2. Pharma Research and Early Development
Roche Only
1. Oncology
RG6279 PD1-IL2v
Solid tumours
4. Phase 1

Description/Summary:

The immunocytokine PD1-IL2v is an antibody fusion protein blocking PD1 combined with an engineered interleukin-2 variant (IL2v) inducing immune-modulating activity

Managed By:
2. Pharma Research and Early Development
Roche Only
1. Oncology
RG6286 NME
Locally advanced or metastatic colorectal cancer
4. Phase 1

Description/Summary:

Managed By:
4. Genentech Research and Early Development
Roche Only
1. Oncology
RG6290 MAGE-A4 ImmTAC
solid tumors
4. Phase 1

Description/Summary:

The trial (NCT03973333) is designed to study the safety and preliminary activity of MAGE-A4 ImmTAC as a monotherapy and in combination with atezolizumab (Tecentriq) in patients with MAGE-A4-expressing cancers.

Managed By:
4. Genentech Research and Early Development
Partner:
Immunocore
1. Oncology
RG6292 Anti-CD25
solid tumors
4. Phase 1

Description/Summary:

RG6292 is a monoclonal antibody that targets CD25 (IL-2Rα). The antibody mediates the depletion of regulatory T-cells (Tregs), a major suppressor of the anti-cancer immune response. RG6292 does not interfere with IL-2 signaling of other immune cells which are acting against the tumor. Phase I clinical trials in solid tumors are evaluating RG6292 as monotherapy (NCT 04158583) and in combination with atezolizumab (NCT04642365).

Managed By:
2. Pharma Research and Early Development
Roche Only
1. Oncology
RG6323 IL15/IL15Ra-Fc
solid tumours
4. Phase 1

Description/Summary:

IL15/IL15Ra-Fc alone, and in combination with Tecentriq

Managed By:
4. Genentech Research and Early Development
Roche Only
1. Oncology
RG6330 KRAS G12C
metastatic solid tumors with KRAS G12C mutation
4. Phase 1

Description/Summary:

Managed By:
4. Genentech Research and Early Development
Roche Only
1. Oncology
RG6433 SHP2i
Solid tumors
4. Phase 1

Description/Summary:

Managed By:
4. Genentech Research and Early Development
Roche Only
1. Oncology
RG7440 Ipatasertib
prostate cancer previously treated with androgen receptor-targeted therapy
4. Phase 1

Description/Summary:

Ipatasertib plus Tecentriq is being tested in a Phase I study in prostate cancer patients who have been previously treated with androgen receptor-targeted therapy

Managed By:
1. Roche Group
Roche Only
1. Oncology
RG7440 ipatasertib
metastatic castration-resistant prostate cancer and solid tumors in combination with rucaparib
4. Phase 1

Description/Summary:

Ipatasertib (RG7440) is a small molecule pan-Akt inhibitor. The PI3K/Akt/mTOR pathway regulates cell growth and survival. A phase I clinical trial is evaluating ipatasertib with rucaparib (a small-molecule PARP inhibitor) for the treatment of metastatic castration-resistant prostate cancer and solid tumors.

Managed By:
1. Roche Group
Partner:
Array BioPharma (ipatasertib), Clovis Oncology (rucaparib)
1. Oncology
RG7446 atezolizumab
Tecentriq
maintenance 1L extensive stage-small cell lung cancer
4. Phase 1

Description/Summary:

Tecentriq plus Venclexta in the treatment of 1L extensive stage-small cell lung cancer in the maintenance setting

Managed By:
1. Roche Group
Roche Only
1. Oncology
RG7446 atezolizumab
Tecentriq
Solid tumors (MORPHEUS platform)
4. Phase 1

Description/Summary:

Cancer immunotherapy is the use of the immune system to fight cancer. Tecentriq (atezolizumab) is a monoclonal antibody that targets PD-L1 (programmed death ligand 1) aiming to prevent cancer immune evasion. MORPHEUS pancreatic cancer study is testing a number of cancer immunotherapy combinations to inform future development. MORPHEUS is a phase Ib/II adaptive development platform established by Roche to assess the efficacy and safety of combination cancer immunotherapies.

Managed By:
1. Roche Group
Partner:
Cotellic in collaboration with Exelixis, BL-8040 in collaboration with BioLineRX, PEGPH20 in collaboration with Halozyme
1. Oncology
RG7601 venetoclax
Venclexta/Venclyxto
relapsed or refractory acute myeloid leukemia in combination with gilteritinib
4. Phase 1

Description/Summary:

Venclexta (venetoclax, RG7601) is a novel small molecule Bcl-2 selective inhibitor designed to restore apoptosis, also known as programmed cell death, by blocking the function of a pro-survival Bcl-2 family protein. The Bcl-2 family proteins, which are expressed at high levels in many tumors, play a central role in regulating apoptosis and, consequently, are thought to impact tumor formation, tumor growth and resistance. A phase I clinical trial is evaluating Venclexta in combination with the gilteritinib for the treatment of patients with relapsed or refractory acute myeloid leukemia.

Managed By:
1. Roche Group
Partner:
AbbVie, Walter and Eliza Hall Institute
1. Oncology
RG7601 venetoclax
Venclexta/Venclyxto
relapsed or refractory myelodysplastic syndromes in combination with azacitidine
4. Phase 1

Description/Summary:

Venclexta (venetoclax, RG7601) is a novel small molecule Bcl-2 selective inhibitor designed to restore apoptosis, also known as programmed cell death, by blocking the function of a pro-survival Bcl-2 family protein. The Bcl-2 family proteins, which are expressed at high levels in many tumors, play a central role in regulating apoptosis and, consequently, are thought to impact tumor formation, tumor growth, and resistance. A phase I clinical trial is evaluating Venclexta as a single agent and in combination with the hypomethylating agent azacitidine in patients with relapsed or refractory myelodysplastic syndromes.

Managed By:
1. Roche Group
Partner:
AbbVie, Walter and Eliza Hall Institute
1. Oncology
RG7601 venetoclax
Venclexta/Venclyxto
relapsed or refractory acute myeloid leukemia, combination with AMG176
4. Phase 1

Description/Summary:

Venclexta (venetoclax, RG7601) is a novel small molecule Bcl-2 selective inhibitor designed to restore apoptosis, also known as programmed cell death, by blocking the function of a pro-survival Bcl-2 family protein. The Bcl-2 family proteins, which are expressed at high levels in many tumors, play a central role in regulating apoptosis and, consequently, are thought to impact tumor formation, tumor growth, and resistance. A phase I clinical trial is investigating Venclexta in combination with AMG176 (Amgen) for the treatment of relapsed or refractory acute myeloid leukemia.

Managed By:
1. Roche Group
Partner:
AbbVie, Walter and Eliza Hall Institute (Venclexta), Amgen
1. Oncology
RG7802 cibisatamab
solid tumors
4. Phase 1

Description/Summary:

cibisatamab (RG7802) is a bispecific antibody designed to simultaneously target carcinoembryonic antigen (CEA) expressed on tumor cells and the CD3 receptor present on T cells, triggering T cell activation, migration and tumor killing. A phase I clinical trial is evaluating cibisatamab for the treatment of CEA-expressing solid tumors, as a single agent and in combination with atezolizumab.

Managed By:
1. Roche Group
Roche Only
1. Oncology
RG7827 FAP 4-1BBL
solid tumors
4. Phase 1

Description/Summary:

RG7827 (FAP 4-1BBL FP) is an agonistic immune modulator and targeted T-cell co-stimulator, which inhibits tumor growth by activating tumor-specific T-cells. RG7827 has an antibody-like structure, with one arm binding to FAP, which is a protein found in the stroma of many solid tumor types, and the other arm carrying the signaling molecule, 4-1BBL. A phase I clinical trial is evaluating RG7827 for the treatment of solid tumors.

Managed By:
2. Pharma Research and Early Development
Roche Only
1. Oncology
RG7828 mosunetuzumab
3L+ Follicular Lymphoma
4. Phase 1
2021

Description/Summary:

mosunetuzumab (Anti-CD20/CD3 TDB, RG7828) is a humanized full-length T cell-dependent bispecific antibody designed to target both CD20 on B cells and CD3 on T cells. This dual-targeting antibody is designed to redirect T cells to attack cancer cells.

Managed By:
4. Genentech Research and Early Development
Roche Only
1. Oncology
RG7828 mosunetuzumab
hematologic tumors
4. Phase 1

Description/Summary:

mosunetuzumab (Anti-CD20/CD3 TDB, RG7828) is a humanized full-length T cell-dependent bispecific antibody designed to target both CD20 on B cells and CD3 on T cells. This dual-targeting antibody is designed to redirect T cells to attack cancer cells. A phase I clinical trial is evaluating mosunetuzumab for the treatment of hematologic tumors.

Managed By:
4. Genentech Research and Early Development
Roche Only
1. Oncology
SQZ PBMC Vaccine
solid tumours
4. Phase 1

Description/Summary:

SQZ-PBMC-HPV as Monotherapy and in Combination With Atezolizumab

Managed By:
2. Pharma Research and Early Development
Roche Only
1. Oncology
RG6058 tiragolumab
1L recurrent/metastatic PD-L1 positive squamous cell head and neck carcinoma
3. Phase 2
2024+

Description/Summary:

Randomised Phase II (SKYSCRAPER-09) 1L recurrent/metastatic PD-L1 positive squamous cell head and neck carcinoma in combination with Tecentriq. tiragolumab (anti-TIGIT, RG6058) is a fully human monoclonal antibody designed to bind to TIGIT and prevent its interaction with poliovirus receptor (PVR). T cell immunoglobulin and ITIM domain protein (TIGIT), a member of the immunoglobulin superfamily, is a novel immune inhibitory receptor.

Managed By:
1. Roche Group
Roche Only
1. Oncology
RG6058 tiragolumab
cervical cancer in combination with tecentriq
3. Phase 2
2024+

Description/Summary:

Randomised Phase II (SKYSCRAPER-04) in metastatic and/or recurrent PD-L1+ cervical cancer in combination with Tecentriq. tiragolumab (anti-TIGIT, RG6058) is a fully human monoclonal antibody designed to bind to TIGIT and prevent its interaction with poliovirus receptor (PVR). T cell immunoglobulin and ITIM domain protein (TIGIT), a member of the immunoglobulin superfamily, is a novel immune inhibitory receptor.

Managed By:
1. Roche Group
Roche Only
1. Oncology
RG6058 tiragolumab
1L non-squamous non-small cell lung cancer (NSCLC) in combination with tecentriq
3. Phase 2

Description/Summary:

Randomised Phase II in 1L non-squamous non-small cell lung cancer (NSCLC) in combination with Tecentriq. tiragolumab (anti-TIGIT, RG6058) is a fully human monoclonal antibody designed to bind to TIGIT and prevent its interaction with poliovirus receptor (PVR). T cell immunoglobulin and ITIM domain protein (TIGIT), a member of the immunoglobulin superfamily, is a novel immune inhibitory receptor.

Managed By:
1. Roche Group
Roche Only
1. Oncology
RG6058-10 tiragolumab
neoadjuvant and adjuvant non-squamous non-small cell lung cancer (NSCLC) in combination with Tecentriq
3. Phase 2

Description/Summary:

Randomised Phase II in neoadjuvant and adjuvant non-squamous non-small cell lung cancer (NSCLC) in combination with Tecentriq. tiragolumab (anti-TIGIT, RG6058) is a fully human monoclonal antibody designed to bind to TIGIT and prevent its interaction with poliovirus receptor (PVR). T cell immunoglobulin and ITIM domain protein (TIGIT), a member of the immunoglobulin superfamily, is a novel immune inhibitory receptor.

Managed By:
1. Roche Group
Roche Only
1. Oncology
RG6139 Anti-PD1 x LAG3
solid tumors
3. Phase 2

Description/Summary:

The bispecific monoclonal antibody PD1 x LAG3 (RG6139) binds to the PD-1 and LAG-3 inhibitory checkpoint receptors on the surface of T-cells. PD1 x LAG3 MAb enable preferential targeting of dysfunctional effector T-cells over regulatory T-cells mediating immunosuppressive effects while restoring anti-tumor immune response. RG6139 is currently in phase I clinical study for solid tumors.

Managed By:
2. Pharma Research and Early Development
Roche Only
1. Oncology
RG6171 giredestrant
neoadjuvant ER+ breast cancer
3. Phase 2
2024+

Description/Summary:

RG6171 (GDC-9545) is a selective estrogen receptor degrader (SERD) that is designed to bind to the estrogen receptor to limit its function. In addition, when SERDs bind to the estrogen receptor, they may be able to change the shape of the receptor in such a way that the cell eliminates it by degradation.

Managed By:
4. Genentech Research and Early Development
Roche Only
1. Oncology
RG6171 giredestrant
ER-positive and HER2-negative 2/3L metastatic breast cancer
3. Phase 2
2022

Description/Summary:

RG6171 (GDC-9545) is a selective estrogen receptor degrader (SERD) that is designed to bind to the estrogen receptor to limit its function. In addition, when SERDs bind to the estrogen receptor, they may be able to change the shape of the receptor in such a way that the cell eliminates it by degradation. A phase II clinical trial is evaluating RG6171 for the treatment of ER-positive and HER2-negative 2/3L metastatic breast cancer.

Managed By:
4. Genentech Research and Early Development
Roche Only
1. Oncology
RG6180 autogene cevumeran
first line melanoma
3. Phase 2
2024+

Description/Summary:

autogene cevumeran (Individualised Neoantigen-Specific Therapy, iNeST (RG6180) is a messenger RNA (mRNA)-based, individually tailored, personalized cancer vaccine. Each vaccine will be made using unique neoantigen signatures from an individual patient’s tumor, which is expected to elicit an effective immune response against that patient’s tumor. A phase II clinical trial is evaluating iNeST for the treatment of first line melanoma.

Managed By:
4. Genentech Research and Early Development
Partner:
BioNTech AG
1. Oncology
RG7601 venetoclax
Venclexta/Venclyxto
relapsed or refractory multiple myeloma
3. Phase 2

Description/Summary:

Venclexta (venetoclax, RG7601) is a novel small molecule Bcl-2 selective inhibitor designed to restore apoptosis, also known as programmed cell death, by blocking the function of a pro-survival Bcl-2 family protein. A phase II clinical trial is evaluating Venclexta in combination with the carfilzomib and dexamethasone for the treatment of patients with relapsed or refractory acute myeloid leukemia.

Managed By:
1. Roche Group
Partner:
AbbVie, Walter and Eliza Hall Institute
1. Oncology
RG7769 Anti-PD1 X TIM3
solid tumors
3. Phase 2

Description/Summary:

RG7769 ( PD1-TIM3) is a bispecific antibody that binds to two co-inhibitory checkpoint receptors, PD-1 and TIM-3, to reinvigorate dysfunctional T-cells enabling them to attack the tumor. A phase I clinical trial is evaluating RG7769 for the treatment of solid tumors.

Managed By:
2. Pharma Research and Early Development
Roche Only
1. Oncology
RG3502 trastuzumab emtansine
Kadcyla
2L+ HER-2 positive PD-L1 positive mBC in combination with Tecentriq
2. Phase 3

Description/Summary:

Trastuzumab emtansine (T–DM1) is a novel antibody–drug conjugate that combines the therapeutic effect of trastuzumab (the active substance of Herceptin) with intracellular delivery of DM1, a highly potent chemotherapy agent, to specifically target HER2-positive tumors.

Managed By:
1. Roche Group
Partner:
ImmunoGen
1. Oncology
RG3502-10 trastuzumab emtansine
Kadcyla
high risk patients with adjuvant HER2-positive breast cancer in combination with Tecentriq
2. Phase 3
2024+

Description/Summary:

Kadcyla (trastuzumab emtansine) is a novel antibody-drug conjugate that combines the therapeutic effect of trastuzumab (the active substance of Herceptin) with intracellular delivery of DM1, a highly potent chemotherapy agent, to specifically target HER2-positive tumors.

Managed By:
1. Roche Group
Partner:
ImmunoGen
1. Oncology
RG6026 Glofitamab
2L+ SCT-ineligible Diffuse Large B-Cell Lymphoma
2. Phase 3
2024+

Description/Summary:

Glofitamab (Anti-CD20 CD3 TCB, RG6026) is a 2:1 format T cell-engaging bispecific antibody, designed to engage both CD20 on B cells and CD3 on T cells. By engaging both targets simultaneously, the antibody activates the T cells to attack and eliminate the B cells, allowing treatment of B cell cancers such as non-Hodgkin’s lymphoma.

Managed By:
2. Pharma Research and Early Development
Roche Only
1. Oncology
RG6058 tiragolumab
locally advanced esophageal cancer
2. Phase 3
2024+

Description/Summary:

Randomised Phase III (SKYSCRAPER-02) of tiragolumab plus Tecentriq in 1L non-small cell lung cancer (NSCLC) patients whose tumours express PD-L1 (TPS>50%). tiragolumab (anti-TIGIT, RG6058) is a fully human monoclonal antibody designed to bind to TIGIT and prevent its interaction with poliovirus receptor (PVR). T cell immunoglobulin and ITIM domain protein (TIGIT), a member of the immunoglobulin superfamily, is a novel immune inhibitory receptor.

Managed By:
1. Roche Group
Roche Only
1. Oncology
RG6058 tiragolumab
stage III unresectable 1L non-small cell lung cancer (NSCLC) in combination with Tecentriq
2. Phase 3
2024+

Description/Summary:

Randomised Phase III (SKYSCRAPER-02) of tiragolumab plus Tecentriq in 1L non-small cell lung cancer (NSCLC) patients whose tumours express PD-L1 (TPS>50%). tiragolumab (anti-TIGIT, RG6058) is a fully human monoclonal antibody designed to bind to TIGIT and prevent its interaction with poliovirus receptor (PVR). T cell immunoglobulin and ITIM domain protein (TIGIT), a member of the immunoglobulin superfamily, is a novel immune inhibitory receptor.

Managed By:
1. Roche Group
Roche Only
1. Oncology
RG6058 tiragolumab
1L non-small cell lung cancer (NSCLC) in combination with Tecentriq
2. Phase 3
2023

Description/Summary:

Randomised Phase III (SKYSCRAPER-02) of tiragolumab plus Tecentriq in 1L non-small cell lung cancer (NSCLC) patients whose tumours express PD-L1 (TPS>50%). tiragolumab (anti-TIGIT, RG6058) is a fully human monoclonal antibody designed to bind to TIGIT and prevent its interaction with poliovirus receptor (PVR). T cell immunoglobulin and ITIM domain protein (TIGIT), a member of the immunoglobulin superfamily, is a novel immune inhibitory receptor.

Managed By:
1. Roche Group
Roche Only
1. Oncology
RG6058 tiragolumab
1L small cell lung cancer (SCLC) in combination with Tecentriq
2. Phase 3
2022

Description/Summary:

Randomised Phase III (SKYSCRAPER-02) of tiragolumab plus Tecentriq in 1L small cell lung cancer (SCLC). tiragolumab (anti-TIGIT, RG6058) is a fully human monoclonal antibody designed to bind to TIGIT and prevent its interaction with poliovirus receptor (PVR). T cell immunoglobulin and ITIM domain protein (TIGIT), a member of the immunoglobulin superfamily, is a novel immune inhibitory receptor.

Managed By:
1. Roche Group
Roche Only
1. Oncology
RG6114 Inavolisib
metastatic ER-positive and HER2-negative breast cancer
2. Phase 3
2023

Description/Summary:

Inavolisib (RG6114, GDC-0077) is a small molecule PI3 kinase (PI3K) inhibitor. Dysregulation of PI3K signaling is implicated in a broad range of human cancers, and activating mutations in the PI3K alpha-isoform gene (PIK3CA) are common oncogenic drivers. The PI3K/Akt/mTOR pathway regulates cell growth and survival.

Managed By:
4. Genentech Research and Early Development
Roche Only
1. Oncology
RG6171 giredestrant
metastatic ER+ breast cancer
2. Phase 3
2024+

Description/Summary:

RG6171 (GDC-9545) is a selective estrogen receptor degrader (SERD) that is designed to bind to the estrogen receptor to limit its function. In addition, when SERDs bind to the estrogen receptor, they may be able to change the shape of the receptor in such a way that the cell eliminates it by degradation.

Managed By:
4. Genentech Research and Early Development
Roche Only
1. Oncology
RG7440 ipatasertib
first line castration-resistant prostate cancer
2. Phase 3
2022

Description/Summary:

Ipatasertib (RG7440) is a small molecule pan-Akt inhibitor. The PI3K/Akt/mTOR pathway regulates cell growth and survival. A phase III clinical trial is evaluating ipatasertib for the treatment of first line castration-resistant prostate cancer.

Managed By:
1. Roche Group
Partner:
Array BioPharma
1. Oncology
RG7446 atezolizumab
Tecentriq
adjuvant renal cell carcinoma
2. Phase 3
2022

Description/Summary:

Cancer immunotherapy is the use of the immune system to fight cancer. Tecentriq, (atezolizumab, anti-PDL1, RG7446, MPDL3280A) is an engineered monoclonal antibody that targets the ligand PD-L1 (programmed death ligand 1) aiming to prevent cancer immune evasion. A phase III clinical trial is evaluating Tecentriq for the treatment of adjuvant renal cell carcinoma.

Managed By:
1. Roche Group
Roche Only
1. Oncology
RG7446 atezolizumab
Tecentriq
adjuvant hepatocellular carcinoma in combination with Avastin
2. Phase 3
2023

Description/Summary:

Cancer immunotherapy is the use of the immune system to fight cancer. Tecentriq (atezolizumab, anti-PDL1, RG7446, MPDL3280A) is an engineered monoclonal antibody that targets the ligand PD-L1 (programmed death ligand 1) aiming to prevent cancer immune evasion. A phase III trial is evaluating Tecentriq in combination with Avastin in adjuvant Hepatocellular carcinoma (HCC)

Managed By:
1. Roche Group
Roche Only
1. Oncology
RG7446 atezolizumab
Tecentriq
adjuvant squamous cell carcinoma of the head and neck
2. Phase 3
2024+

Description/Summary:

Cancer immunotherapy is the use of the immune system to fight cancer. Tecentriq, (atezolizumab, anti-PDL1, RG7446, MPDL3280A) is an engineered monoclonal antibody that targets the ligand PD-L1 (programmed death ligand 1) aiming to prevent cancer immune evasion. A phase III trial is evaluating Tecentriq in patients with adjuvant squamous cell carcinoma of the head and neck (SCCHN).

Managed By:
1. Roche Group
Roche Only
1. Oncology
RG7446 atezolizumab
Tecentriq
first line metastatic urothelial carcinoma
2. Phase 3
2022

Description/Summary:

Cancer immunotherapy is the use of the immune system to fight cancer. Tecentriq, (atezolizumab, anti-PDL1, RG7446, MPDL3280A) is an engineered monoclonal antibody that targets the ligand PD-L1 (programmed death ligand 1) aiming to prevent cancer immune evasion. A phase III trial is evaluating Tecentriq in combination with chemotherapy or as monotherapy in patients with locally advanced or metastatic urothelial carcinoma who have not received prior systemic therapy.

Managed By:
1. Roche Group
Roche Only
1. Oncology
RG7446 atezolizumab
Tecentriq
Non-small cell lung cancer subcutaneous formulation
2. Phase 3
2023

Description/Summary:

Cancer immunotherapy is the use of the immune system to fight cancer. Atezolizumab (anti-PDL1, RG7446, MPDL3280A) is an engineered monoclonal antibody that targets the ligand PD-L1 (programmed death ligand 1) aiming to prevent cancer immune evasion.

Managed By:
1. Roche Group
Roche Only
1. Oncology
RG7446 atezolizumab
Tecentriq
first line metastatic triple-negative breast cancer in combination with capecitabine or carboplatin/gemcitabine
2. Phase 3
2024+

Description/Summary:

Cancer immunotherapy is the use of the immune system to fight cancer. Tecentriq (anti-PDL1, RG7446, atezolizumab) is an engineered monoclonal antibody that targets the ligand PD-L1 (programmed death ligand 1) aiming to prevent cancer immune evasion. Tecentriq is being evaluated in a phase III clinical trial as a potential first-line treatment, in combination with capecitabine or carboplatin/gemcitabine, for metastatic triple-negative breast cancer.

Managed By:
1. Roche Group
Roche Only
1. Oncology
RG7446 atezolizumab
Tecentriq
adjuvant triple-negative breast cancer in combination with paclitaxel
2. Phase 3
2024+

Description/Summary:

Cancer immunotherapy is the use of the immune system to fight cancer. Tecentriq (anti-PDL1, RG7446, Atezolizumab) is an engineered monoclonal antibody that targets the ligand PD-L1 (programmed death ligand 1) aiming to prevent cancer immune evasion. Tecentriq is being evaluated in a phase III clinical trial as a potential adjuvant treatment, in combination with paclitaxel, for triple-negative breast cancer.

Managed By:
1. Roche Group
Roche Only
1. Oncology
RG7446 atezolizumab
Tecentriq
2L non small cell lung cancer (NSCLC) treatment in combination with cabozantinib
2. Phase 3
2023

Description/Summary:

Cancer immunotherapy is the use of the immune system to fight cancer. Tecentriq (anti-PDL1, RG7446, atezolizumab) is an engineered monoclonal antibody that targets the ligand PD-L1 (programmed death ligand 1) aiming to prevent cancer immune evasion. A phase III trial is evaluating Tecentriq in combination with cabozantinib for the treatment of 2L non small cell lung cancer (NSCLC)

Managed By:
1. Roche Group
Roche Only
1. Oncology
RG7446 atezolizumab
Tecentriq
Advanced renal cell carcinoma after immune checkpoint inhibitor treatment in combination with cabozantinib
2. Phase 3
2023

Description/Summary:

Cancer immunotherapy is the use of the immune system to fight cancer. Tecentriq (anti-PDL1, RG7446, atezolizumab) is an engineered monoclonal antibody that targets the ligand PD-L1 (programmed death ligand 1) aiming to prevent cancer immune evasion. A phase III trial is evaluating Tecentriq in combination with cabozantinib for the treatment of advanced renal cell carcinoma after immune checkpoint inhibitor treatment

Managed By:
1. Roche Group
Roche Only
1. Oncology
RG7446-42 atezolizumab
Tecentriq
ctDNA+ high risk muscle-invasive bladder cancer
2. Phase 3
2024+

Description/Summary:

Cancer immunotherapy is the use of the immune system to fight cancer. Tecentriq (anti-PDL1, RG7446, atezolizumab) is an engineered monoclonal antibody that targets the ligand PD-L1 (programmed death ligand 1) aiming to prevent cancer immune evasion.

Managed By:
1. Roche Group
Roche Only
1. Oncology
RG7596 polatuzumab vedotin
Polivy
first line diffuse large B-cell lymphoma
2. Phase 3
2021

Description/Summary:

Polivy (Polatuzumab vedotin) is an antibody-drug conjugate (ADC) that consists of a monoclonal antibody anti-CD79b, conjugated to a potent anti-cancer agent that is selectively delivered to tumor cells. A phase III clinical trial is evaluating Polivy for the treatment of first line diffuse large B-cell lymphoma.

Managed By:
1. Roche Group
Partner:
Seattle Genetics
1. Oncology
RG7601 venetoclax
Venclexta/Venclyxto
Newly diagnosed higher-risk myelodysplastic syndrome
2. Phase 3
2024+

Description/Summary:

Venclexta (venetoclax, RG7601) is a novel small molecule Bcl-2 selective inhibitor designed to restore apoptosis, also known as programmed cell death, by blocking the function of a pro-survival Bcl-2 family protein. The Bcl-2 family proteins, which are expressed at high levels in many tumors, play a central role in regulating apoptosis and, consequently, are thought to impact tumor formation, tumor growth, and resistance.

Managed By:
1. Roche Group
Partner:
AbbVie, Walter and Eliza Hall Institute
1. Oncology
RG7601 venetoclax
Venclexta/Venclyxto
relapsed or refractory t(11;14)-positive multiple myeloma
2. Phase 3
2023

Description/Summary:

Venclexta (venetoclax, RG7601, GDC-0199, ABT-199) is a novel small molecule Bcl-2 selective inhibitor designed to restore apoptosis, also known as programmed cell death, by blocking the function of a pro-survival Bcl-2 family protein. The Bcl-2 family proteins, which are expressed at high levels in many tumors, play a central role in regulating apoptosis and, consequently, are thought to impact tumor formation, tumor growth and resistance. A phase III clinical trial is evaluating Venclexta for the treatment of relapsed or refractory t(11;14)-positive multiple myeloma.

Managed By:
1. Roche Group
Partner:
AbbVie, Walter and Eliza Hall Institute
1. Oncology
RG7828 mosunetuzumab
2L+ Follicular Lymphoma
2. Phase 3
2024+

Description/Summary:

mosunetuzumab (Anti-CD20/CD3 TDB, RG7828) is a humanized full-length T cell-dependent bispecific antibody designed to target both CD20 on B cells and CD3 on T cells. This dual-targeting antibody is designed to redirect T cells to attack cancer cells.

Managed By:
4. Genentech Research and Early Development
Roche Only
1. Oncology
RG7853 alectinib
Alecensa
adjuvant ALK-positive non-small cell lung cancer
2. Phase 3
2022

Description/Summary:

Alecensa (Alectinib, RG7853) is a small molecule designed to selectively target ALK (anaplastic lymphoma kinase) and to penetrate and stay in the central nervous system. Alectinib binds ALK, inhibiting downstream malignant pathways that contribute to tumorigenesis and disease progression. A phase III clinical trial is evaluating Alecensa for the treatment of adjuvant ALK-positive non-small cell lung cancer.

Managed By:
1. Roche Group
Partner:
Chugai
1. Oncology
RG7446 atezolizumab
Tecentriq
neoadjuvant triple-negative breast cancer
1. Filed
2020

Description/Summary:

Cancer immunotherapy is the use of the immune system to fight cancer. Tecentriq (atezolizumab, anti-PDL1, RG7446, MPDL3280A) is an engineered monoclonal antibody that targets the ligand PD-L1 (programmed death ligand 1) aiming to prevent cancer immune evasion. A phase III clinical trial is investigating Tecentriq in combination with nab-paclitaxel (Abraxane) as a potential neoadjuvant (before surgery) treatment for triple-negative breast cancer.

Managed By:
1. Roche Group
Roche Only
1. Oncology
RG7446 atezolizumab
Tecentriq
adjuvant non-small cell lung cancer
1. Filed
2021

Description/Summary:

Cancer immunotherapy is the use of the immune system to fight cancer. Tecentriq (anti-PDL1, RG7446, Atezolizumab ) is an engineered monoclonal antibody that targets the ligand PD-L1 (programmed death ligand 1) aiming to prevent cancer immune evasion. Tecentriq is being evaluated in a phase III clinical trial as a potential adjuvant treatment, following surgery and adjuvant cisplatin-based chemotherapy, for patients with non-small cell lung cancer whose tumors express PDL1.

Managed By:
1. Roche Group
Roche Only

2. Immunology

2. Immunology
RG6107 crovalimab
paroxysmal nocturnal hemoglobinuria
4. Phase 1

Description/Summary:

Crovalimab (RG6107) is a humanised complement inhibitor C5 monoclonal antibody discovered by Chugai using recycling antibody technology. By blocking the cleavage of C5 to C5a and C5b, it is expected to inhibit complement activation, which is the cause of a number of diseases. As the complement system is a key innate immune defense mechanism, we plan to study the potential of this antibody in a broader range of complement-mediated diseases. A phase I/II clinical trial is evaluating crovalimab for the treatment of paroxysmal nocturnal hemoglobinuria.

Managed By:
1. Roche Group
Partner:
Chugai
2. Immunology
RG6287
Inflammatory bowel disease
4. Phase 1

Description/Summary:

Managed By:
4. Genentech Research and Early Development
Roche Only
2. Immunology
RG6315 NME
Systemic Sclerosis
4. Phase 1

Description/Summary:

Managed By:
4. Genentech Research and Early Development
Roche Only
2. Immunology
RG6418 NLRP3 inhibitor
Inflammation
4. Phase 1

Description/Summary:

Managed By:
2. Pharma Research and Early Development
Roche Only
2. Immunology
IONIS ASO factor B
IgA-nephropathy
3. Phase 2

Description/Summary:

ASO factor B (IONIS) is an antisense oligonucleotide that inhibits complement factor B gene expression by binding with factor B mRNA. ASO factor B is being studied for the treatment of IgA-nephropathy. A phase II clinical trial is evaluating ASO factor B for the treatment of IgA-nephropathy.

Managed By:
0. -
Partner:
Ionis
2. Immunology
RG6173
asthma
3. Phase 2

Description/Summary:

Managed By:
4. Genentech Research and Early Development
Roche Only
2. Immunology
RG6354 recombinant human pentraxin-2
myelofibrosis
3. Phase 2
2024+

Description/Summary:

Phase II study of pentraxin-2 (rhPTX-2; PRM-151) in myelofibrosis

Managed By:
1. Roche Group
Roche Only
2. Immunology
RG7835 IgG-IL2
autoimmune diseases
3. Phase 2

Description/Summary:

RG7835 is a conjugate of human IL-2 and IgG (fused IL-2 mutein). IgG–IL2 preferentially stimulates and expands T regulatory cells but not T effector cells. A phase I clinical trial is evaluating RG7835 for the treatment of autoimmune diseases.

Managed By:
2. Pharma Research and Early Development
Roche Only
2. Immunology
RG7880 IL22-Fc
inflammatory diseases
3. Phase 2
2024+

Description/Summary:

RG7880 (IL22-Fc, UTTR1147A) is a recombinant human protein with potential application across multiple inflammatory and metabolic diseases. A phase II clinical trial is evaluating RG7880 for the treatment of inflammatory diseases.

Managed By:
4. Genentech Research and Early Development
Roche Only
2. Immunology
RG1569 tocilizumab
Actemra/RoACTEMRA
Covid-19 pneumonia
2. Phase 3
2021

Description/Summary:

Actemra/RoACTEMRA (tocilizumab) is a humanised monoclonal antibody to the interleukin-6 receptor, inhibiting the activity of interleukin-6 and is being investigated in the treatment of Covid-19 pneumonia.

Managed By:
1. Roche Group
Roche Only
2. Immunology
RG3648 omalizumab
Xolair
Food allergy
2. Phase 3
2022

Description/Summary:

Xolair (omalizumab, RG3648) is a monoclonal antibody that specifically targets the antibody IgE (immunoglobulin E). In nasal polyps (NP) IgE is increased in mucosal tissue and frequently in serum.

Managed By:
1. Roche Group
Partner:
Novartis
2. Immunology
RG6107 crovalimab
Paroxysmal Nocturnal Hemoglobinuria (PNH) C5 inhibitor naive patients
2. Phase 3
2022

Description/Summary:

Crovalimab (RG6107) is a humanised complement inhibitor C5 monoclonal antibody discovered by Chugai using recycling antibody technology. By blocking the cleavage of C5 to C5a and C5b, it is expected to inhibit complement activation, which is the cause of a number of diseases. As the complement system is a key innate immune defense mechanism, we plan to study the potential of this antibody in a broader range of complement-mediated diseases.

Managed By:
1. Roche Group
Partner:
Chugai
2. Immunology
RG6107 crovalimab
Paroxysmal Nocturnal Hemoglobinuria (PNH) patients switching from a C5 inhibitor
2. Phase 3
2024+

Description/Summary:

Crovalimab (RG6107) is a humanised complement inhibitor C5 monoclonal antibody discovered by Chugai using recycling antibody technology. By blocking the cleavage of C5 to C5a and C5b, it is expected to inhibit complement activation, which is the cause of a number of diseases. As the complement system is a key innate immune defense mechanism, we plan to study the potential of this antibody in a broader range of complement-mediated diseases.

Managed By:
1. Roche Group
Partner:
Chugai
2. Immunology
RG6354 recombinant human pentraxin-2
Idiopathic pulmonary fibrosis
2. Phase 3
2024+

Description/Summary:

Phase II study of pentraxin-2 (rhPTX-2; PRM-151) in idiopathic pulmonary fibrosis

Managed By:
1. Roche Group
Roche Only
2. Immunology
RG7159 obinutuzumab
Gazyva/Gazyvaro
lupus nephritis
2. Phase 3
2024+

Description/Summary:

Obinutuzumab (RG7159, GA101) is the first glycoengineered, type II, humanised anti-CD20 monoclonal antibody. It has a distinct mode of action compared with other anti-CD20s, including MabThera/Rituxan, and was specifically designed to selectively target the CD20 protein on B cells and to bind with high affinity to the cell surface in a type II configuration.

Managed By:
1. Roche Group
Partner:
Biogen Idec
2. Immunology
RG7159-7 obinutuzumab
Gazyva/Gazyvaro
membranous Nephropathy
2. Phase 3
2024+

Description/Summary:

Obinutuzumab (RG7159, GA101) is the first glycoengineered, type II, humanised anti-CD20 monoclonal antibody. It has a distinct mode of action compared with other anti-CD20s, including MabThera/Rituxan, and was specifically designed to selectively target the CD20 protein on B cells and to bind with high affinity to the cell surface in a type II configuration.

Managed By:
1. Roche Group
Partner:
Biogen Idec
2. Immunology
RG7413 etrolizumab
Crohn's disease
2. Phase 3
2022

Description/Summary:

Etrolizumab (RG7413) is a humanized IgG1 MAb targeting the beta 7 integrin subunit. It binds to two integrin receptors, alpha4beta7 and alphaEbeta7. These receptors are required for trafficking and retention in lymphocytes in the gastrointestinal tract and appear to play a role in inflammatory bowel diseases. Phase III clinical trials are evaluating etrolizumab for the treatment of Crohn's disease.

Managed By:
1. Roche Group
Roche Only

3. Ophthalmology

3. Ophthalmology
RG6120 VEGF-Ang2 DutaFab
neovascular age-related macular degeneration
4. Phase 1

Description/Summary:

RG6120 (VEGF-Ang2 DutaFab) is a bispecific Fab molecule targeting vascular endothelial growth factor (VEGF) and Angiopoietin 2 (Ang-2). Built on the DutaFab platform, RG6120 is specifically designed to be compatible with the Port Delivery System.

Managed By:
2. Pharma Research and Early Development
Roche Only
3. Ophthalmology
RG6179
diabetic macular edema
4. Phase 1

Description/Summary:

Managed By:
2. Pharma Research and Early Development
Roche Only
3. Ophthalmology
RG6312 NME
geographic atrophy
4. Phase 1

Description/Summary:

Managed By:
4. Genentech Research and Early Development
Roche Only
3. Ophthalmology
RG7921
neovascular age related macular degeneration
4. Phase 1

Description/Summary:

Managed By:
2. Pharma Research and Early Development
Roche Only
3. Ophthalmology
IONIS ASO factor B
geographic atrophy
3. Phase 2

Description/Summary:

ASO factor B (IONIS) is an antisense oligonucleotide that inhibits complement factor B gene expression by binding with factor B mRNA. ASO factor B is being studied for the treatment of geographic atrophy. A phase II clinical trial is evaluating ASO factor B for the treatment of geographic atrophy.

Managed By:
0. -
Partner:
Ionis
3. Ophthalmology
RG6147
geographic atrophy
3. Phase 2

Description/Summary:

HtrA1

Managed By:
4. Genentech Research and Early Development
Roche Only
3. Ophthalmology
RG7774 NME
retinal disease
3. Phase 2

Description/Summary:

Managed By:
2. Pharma Research and Early Development
Roche Only
3. Ophthalmology
RG6321 Port Delivery System with ranibizumab
diabetic retinopathy without center-involved diabetic macular edema
2. Phase 3
2023

Description/Summary:

Ranibizumab, the active ingredient of Lucentis, is a monoclonal antibody fragment. It is designed to bind to and inhibit VEGF (vascular endothelial growth factor), a protein that is believed to play a critical role in the formation of new blood vessels (angiogenesis) and the hyperpermeability (leakiness) of the vessels. A phase III clinical trial is evaluating ranibizumab delivered via the ranibizumab port delivery system implant for the treatment of patients with subfoveal neovascular age-related macular degeneration. The primary outcome measure of the trial is the time until a patient first requires a refill of the implant.

Managed By:
1. Roche Group
Partner:
ForSight VISION4
3. Ophthalmology
RG6321 Port Delivery System with ranibizumab
diabetic macular edema
2. Phase 3
2023

Description/Summary:

Ranibizumab (RG6321), the active ingredient of Lucentis, is a monoclonal antibody fragment. It is designed to bind to and inhibit VEGF (vascular endothelial growth factor), a protein that is believed to play a critical role in the formation of new blood vessels (angiogenesis) and the hyperpermeability (leakiness) of the vessels. A phase III clinical trial is evaluating ranibizumab delivered via the port delivery system implant for the treatment of patients with diabetic macular edema (DME).

Managed By:
1. Roche Group
Partner:
ForSight VISION4
3. Ophthalmology
RG6321-3 Port Delivery System with ranibizumab
age-related macular -36 week refill interval
2. Phase 3
2024+

Description/Summary:

Ranibizumab, the active ingredient of Lucentis, is a monoclonal antibody fragment. It is designed to bind to and inhibit VEGF (vascular endothelial growth factor), a protein that is believed to play a critical role in the formation of new blood vessels (angiogenesis) and the hyperpermeability (leakiness) of the vessels. A phase III clinical trial is evaluating ranibizumab delivered via the ranibizumab port delivery system implant refilled every 36 weeks for the treatment of patients with subfoveal neovascular age-related macular degeneration. The primary outcome measure of the trial is the time until a patient first requires a refill of the implant.

Managed By:
1. Roche Group
Partner:
ForSight VISION4
3. Ophthalmology
RG7716 faricimab
Macular edema secondary to branch retinal vein occlusion
2. Phase 3
2023

Description/Summary:

Faricimab (RG7716) is a bispecific antibody developed with CrossMab technology to tightly bind VEGF-A on one arm and angiopoietin (Ang)-2 on the other arm.

Managed By:
1. Roche Group
Roche Only
3. Ophthalmology
RG7716 faricimab
Macular edema secondary to central retinal vein occlusion
2. Phase 3
2023

Description/Summary:

Faricimab (RG7716) is a bispecific antibody developed with CrossMab technology to tightly bind VEGF-A on one arm and angiopoietin (Ang)-2 on the other arm.

Managed By:
1. Roche Group
Roche Only
3. Ophthalmology
RG6321 Port Delivery System with ranibizumab
age-related macular degeneration
1. Filed
2020

Description/Summary:

Ranibizumab, the active ingredient of Lucentis, is a monoclonal antibody fragment. It is designed to bind to and inhibit VEGF (vascular endothelial growth factor), a protein that is believed to play a critical role in the formation of new blood vessels (angiogenesis) and the hyperpermeability (leakiness) of the vessels. A phase III clinical trial is evaluating ranibizumab delivered via the ranibizumab port delivery system implant for the treatment of patients with subfoveal neovascular age-related macular degeneration. The primary outcome measure of the trial is the time until a patient first requires a refill of the implant.

Managed By:
1. Roche Group
Partner:
ForSight VISION4
3. Ophthalmology
RG7716 faricimab
diabetic macular edema
1. Filed
2021

Description/Summary:

Faricimab (RG7716) is a bispecific antibody developed with CrossMab technology to tightly bind VEGF-A on one arm and angiopoietin (Ang)-2 on the other arm. Two phase III clinical trials are evaluating faricimab for the treatment of diabetic macular edema.

Managed By:
1. Roche Group
Roche Only
3. Ophthalmology
RG7716 faricimab
neovascular age related macular degeneration
1. Filed
2021

Description/Summary:

Faricimab (RG7716) is a bispecific antibody developed with CrossMab technology to tightly bind VEGF-A on one arm and angiopoietin (Ang)-2 on the other arm. Two phase III clinical trials are evaluating faricimab for the treatment of neovascular age related macular degeneration.

Managed By:
1. Roche Group
Roche Only

4. Infectious Diseases

4. Infectious Diseases
RG6006 Abx MCP
Acinetobacter baumannii infections
4. Phase 1

Description/Summary:

RG6006 (Abx MCP) is a small molecule, novel chemical class antibiotic for the treatment of Acinetobacter baumannii infections.

Managed By:
2. Pharma Research and Early Development
Roche Only
4. Infectious Diseases
RG6084 PD-L1 LNA
chronic hepatitis B infection
4. Phase 1

Description/Summary:

RG6084 (PD-L1 LNA) is a liver-directed locked nucleic acid oligonucleotide targeting the PD-L1/PD-1 immune checkpoint inhibitory pathway, which is overexpressed in the liver of patients with chronic hepatitis B.

Managed By:
2. Pharma Research and Early Development
Roche Only
4. Infectious Diseases
RG7854
chronic hepatitis B infection
4. Phase 1

Description/Summary:

TLR7 agonist (RG7854) is an oral, small molecule immuno-modulator activating the TLR (toll-like receptor) 7 and to a weaker extent TLR8. It is developed as best-in-disease for finite chronic hepatitis B combination therapy. A phase I clinical trial is evaluating RG7854 for the treatment of chronic hepatitis B infection.

Managed By:
2. Pharma Research and Early Development
Roche Only
4. Infectious Diseases
RG7907
chronic hepatitis B infection
4. Phase 1

Description/Summary:

CpAM (RG7907) is an orally administered small molecule, class I hepatitis B virus (HBV) core protein allosteric modulator, that disrupts HBV nucleocapsids assembly and induces the depletion of functional core proteins, thereby effectively inhibiting HBV replication. A phase I clinical trial is evaluating RG7907 for the treatment of chronic hepatitis B infection.

Managed By:
2. Pharma Research and Early Development
Roche Only
4. Infectious Diseases
RG6346 HBV siRNA
Hepatitis B virus
3. Phase 2

Description/Summary:

RG6346 (DCR-HBVS) is a liver-targeted siRNA that employs RNA interference (RNAi) for selective knock-down of Hepatitis B virus gene expression in infected hepatocytes, inhibiting the production of viral factors required for viral replication. RG6346 leverages Dicerna Pharmaceuticals, Inc.’s proprietary GalXC™ RNAi technology. RG6346 is in a phase I clinical trial for the treatment of non-cirrhotic chronic HBV infection.

Managed By:
2. Pharma Research and Early Development
Roche Only
4. Infectious Diseases
RG6412 imdevimab
REGEN-COV-2
ambulatory adult patients with COVID-19
3. Phase 2

Description/Summary:

Managed By:
0. -
Partner:
Regeneron
4. Infectious Diseases
RG6412 imdevimab
REGEN-COV-2
hospitalised adult patients with COVID-19
3. Phase 2

Description/Summary:

Managed By:
0. -
Partner:
Regeneron
4. Infectious Diseases
RG6413 casivirimab
REGEN-COV-2
hospitalized patients with COVID-19
3. Phase 2
2021

Description/Summary:

Managed By:
0. -
Partner:
Regeneron
4. Infectious Diseases
RG6413 casivirimab
REGEN-COV-2
ambulatory patients with COVID-19
3. Phase 2
2021

Description/Summary:

Managed By:
0. -
Partner:
Regeneron
4. Infectious Diseases
RG7854
chronic hepatitis B infection
3. Phase 2

Description/Summary:

TLR7 agonist (RG7854) in combination with RG7907 CpAM (2)

Managed By:
2. Pharma Research and Early Development
Roche Only
4. Infectious Diseases
RG6152 baloxavir marboxil
Xofluza
influenza, direct transmission
2. Phase 3
2023

Description/Summary:

Xofluza (baloxavir marboxil, RG6152) is an oral cap-dependent endonuclease inhibitor with broad and potent antiviral activity against seasonal influenza A and B viruses.

Managed By:
1. Roche Group
Partner:
Shionogi
4. Infectious Diseases
RG6152 baloxavir marboxil
Xofluza
influenza, pediatric patients (0-1yr)
2. Phase 3
2022

Description/Summary:

Xofluza (baloxavir marboxil, RG6152) is an oral cap-dependent endonuclease inhibitor with broad and potent antiviral activity against seasonal influenza A and B viruses. Xofluza is being evaluated in a phase III clinical trial for the treatment of pediatric patients with the flu.

Managed By:
1. Roche Group
Partner:
Shionogi
4. Infectious Diseases
RG6412 imdevimab
REGEN-COV-2
Prevention of SARS CoV-2 Infection, asymptomatic in healthy adults who are household contacts to an Individual With a Positive SARS-CoV-2 RT-PCR Assay
2. Phase 3

Description/Summary:

Managed By:
0. -
Partner:
Regeneron
4. Infectious Diseases
RG6412 imdevimab
REGEN-COV-2
SARS-COV2 adult ambulatory
2. Phase 3

Description/Summary:

Managed By:
0. -
Partner:
Regeneron
4. Infectious Diseases
RG6413 casivirimab
REGEN-COV-2
SARS-COV-2 ambulatory
2. Phase 3

Description/Summary:

Managed By:
0. -
Partner:
Regeneron
4. Infectious Diseases
RG6413 casivirimab
REGEN-COV-2
Prevention of SARS CoV-2 Infection, asymptomatic in healthy adults who are household contacts to an Individual With a Positive SARS-CoV-2 RT-PCR Assay
2. Phase 3
2021

Description/Summary:

Managed By:
0. -
Partner:
Regeneron
4. Infectious Diseases
RG6422 AT-527
Adult non-hospitalised SARS-COV-2
2. Phase 3

Description/Summary:

Managed By:
1. Roche Group
Partner:
Atea
4. Infectious Diseases
RG6152 baloxavir marboxil
Xofluza
influenza, pediatric patients (1-12yr)
1. Filed
2021

Description/Summary:

Xofluza (baloxavir marboxil, RG6152) is an oral cap-dependent endonuclease inhibitor with broad and potent antiviral activity against seasonal influenza A and B viruses. Xofluza is being evaluated in a phase III clinical trial for the treatment of pediatric patients with the flu.

Managed By:
1. Roche Group
Partner:
Shionogi

5. CardioMetabolism

5. CardioMetabolism
CHU
hypoparathyroidism
4. Phase 1

Description/Summary:

PCO371 is an orally available small molecule parathyroid hormone (PTH1) receptor agonist for hypoparathyroidism. The compound is expected to stabilize blood calcium levels without causing hypercalciuria, a major concern in conventional treatment with oral activated vitamin D and calcium. A phase I clinical trial is evaluating PCO371 for the treatment of hypoparathyroidism.

Managed By:
3. Chugai
Partner:
Chugai
5. CardioMetabolism
RG6338 NME
metabolic diseases
4. Phase 1

Description/Summary:

Managed By:
4. Genentech Research and Early Development
Roche Only
5. CardioMetabolism
RG7992 FGFR1 x KLB
metabolic diseases
4. Phase 1

Description/Summary:

RG7992 (anti-FGFR1/KLB, BFKB8488A) is a bispecific antibody designed to mimic the metabolic hormone FGF21. A phase II clinical trial is evaluating RG7992 for the treatment of metabolic diseases

Managed By:
4. Genentech Research and Early Development
Roche Only
5. CardioMetabolism
RG6359 SPK-3006
Pompe disease
3. Phase 2

Description/Summary:

Managed By:
1. Roche Group
Roche Only
5. CardioMetabolism
RG7992 FGFR1 x KLB
Non-Alcoholic SteatoHepatitis (NASH)
3. Phase 2
2024+

Description/Summary:

RG7992 (anti-FGFR1/KLB, BFKB8488A) is a bispecific antibody designed to mimic the metabolic hormone FGF21. A phase II clinical trial is evaluating RG7992 for the treatment of Non-Alcoholic SteatoHepatitis (NASH)

Managed By:
4. Genentech Research and Early Development
Roche Only

6. Neuroscience

6. Neuroscience
RG6091 UBE3-LNA
Angelman syndrome
4. Phase 1

Description/Summary:

UBE3A-LNA is a locked nucleic acid developed for the treatment of Angelman syndrome which is caused by a lack of UBE3A expression in the brain. The LNA targets the paternal antisense RNA and enables the expression of UB3A in neurons.

Managed By:
2. Pharma Research and Early Development
Roche Only
6. Neuroscience
RG6182 NME
neurodegenerative diseases
4. Phase 1

Description/Summary:

Managed By:
2. Pharma Research and Early Development
Roche Only
6. Neuroscience
RG6237
neuromuscular disorders
4. Phase 1

Description/Summary:

Managed By:
2. Pharma Research and Early Development
Roche Only
6. Neuroscience
RG7637 NME
neurodevelopmental disorders
4. Phase 1

Description/Summary:

Managed By:
2. Pharma Research and Early Development
Roche Only
6. Neuroscience
RG6100 semorinemab
Alzheimer's disease
3. Phase 2
2024+

Description/Summary:

RG6100 (Anti Tau) is an investigational medicine being evaluated as a potential treatment for Alzheimer’s disease. A phase II clinical trial is evaluating RG6100 for the treatment of patients with Alzheimer's disease.

Managed By:
4. Genentech Research and Early Development
Partner:
AC Immune
6. Neuroscience
RG6102 Brain shuttle gantenerumab
Alzheimer's
3. Phase 2
2024+

Description/Summary:

Brain shuttle technology to transfer gantenerumab across the blood brain barrier and increase antibody concentrations in the brain

Managed By:
2. Pharma Research and Early Development
Roche Only
6. Neuroscience
RG6356 microdystrophin (SRP-9001)
Duchenne muscular dystrophy
3. Phase 2
2024+

Description/Summary:

Phase II gene therapy in Duchenne muscular dystrophy (DMD)

Managed By:
1. Roche Group
Roche Only
6. Neuroscience
RG7412 crenezumab
Alzheimer's disease
3. Phase 2
2024+

Description/Summary:

Crenezumab (RG7412) is a humanized monoclonal antibody, which binds to amyloid beta (Abeta). Abeta is the main constituent of amyloid plaque in the brains of patients with Alzheimer's disease and is proposed to be causative in the development of the disease. A phase II clinical trial is evaluating crenezumab in healthy individuals with a history of familial Alzheimer’s disease.

Managed By:
1. Roche Group
Partner:
AC Immune
6. Neuroscience
RG7816 GABA-Aa5 PAM
autism spectrum disorder
3. Phase 2
2024+

Description/Summary:

RG7816 is a small molecule highly selective positive allosteric modulator of the GABAA α5 receptor, which is expressed in key brain regions for autism spectrum disorder. Two phase I clinical trial is evaluating RG7816 for the treatment of patients with autism spectrum disorder.

Managed By:
2. Pharma Research and Early Development
Roche Only
6. Neuroscience
RG7906 ralmitaront
psychiatric disorders
3. Phase 2

Description/Summary:

Managed By:
2. Pharma Research and Early Development
Roche Only
6. Neuroscience
RG7935 prasinezumab
Parkinson's disease
3. Phase 2
2024+

Description/Summary:

Prasinezumab (RG7935) is a monoclonal antibody targeting alpha-synuclein, a protein that may misfold and be involved in the pathogenesis of Parkinson's disease. It has been tested in preclinical models of synuclein-related disease and has shown a reduction of neurodegeneration. A phase II clinical trial is evaluating prasinezumab for the treatment of patients with Parkinson's disease.

Managed By:
2. Pharma Research and Early Development
Partner:
Prothena
6. Neuroscience
RG1450 gantenerumab
Alzheimer's disease
2. Phase 3
2022

Description/Summary:

Gantenerumab (RG1450) is a fully human monoclonal antibody that binds and neutralises disease-relevant aggregated forms of amyloid-beta: those that accumulate as plaques in the brain and those which interfere with brain-cell functioning. A phase III clinical trial is evaluating gantenerumab for the treatment of Alzheimer's disease.

Managed By:
1. Roche Group
Partner:
Morphosys
6. Neuroscience
RG6042 tominersen
Huntington's Disease
2. Phase 3

Description/Summary:

tominersen (ASO-HTT, RG6042) is an antisense drug in development for the treatment of Huntington's Disease. tominersen is designed to reduce the production of all forms of the huntingtin (HTT) protein, which in its mutated variant (mHTT) is responsible for Huntington's Disease. Multiple clinical trials are evaluating tominersen for the treatment of patients with Huntington's Disease.

Managed By:
1. Roche Group
Partner:
Ionis
6. Neuroscience
RG7845 fenebrutinib
Relapsing multiple sclerosis (RMS)
2. Phase 3
2024+

Description/Summary:

RG7845 (GDC-0853) is a novel Bruton’s tyrosine kinase (BTK) inhibitor that helps block B cell proliferation. RG7845 binds to BTK in a novel way that is believed to increase its effectiveness.

Managed By:
1. Roche Group
Roche Only
6. Neuroscience
RG7845 fenebrutinib
Primary progressive multiple sclerosis (PPMS)
2. Phase 3
2024+

Description/Summary:

RG7845 (GDC-0853) is a novel Bruton’s tyrosine kinase (BTK) inhibitor that helps block B cell proliferation. RG7845 binds to BTK in a novel way that is believed to increase its effectiveness.

Managed By:
1. Roche Group
Roche Only

7. Other

7. Other
CHU
endometriosis
4. Phase 1

Description/Summary:

Managed By:
3. Chugai
Partner:
Chugai
7. Other
CHU anti-FIXa/FX
hemophilia A
4. Phase 1

Description/Summary:

NXT007 is an optimized anti-FIXa/FX bispecific monoclonal antibody. NXT007 has an enhanced hemostatic activity and improved pharmacokinetics by antibody engineering technologies. The bispecific antibody is in phase I/II clinical study for healthy volunteers and hemophilia A.

Managed By:
3. Chugai
Roche Only
7. Other
RG6357 SPK-8011
hemophilia A
3. Phase 2

Description/Summary:

Managed By:
0. -
Roche Only
7. Other
RG6358 SPK-8016
hemophilia A with inhibitors to factor VIII
3. Phase 2

Description/Summary:

Managed By:
0. -
Roche Only
7. Other
RG6367 sPK-7001
choroideremia
3. Phase 2

Description/Summary:

Managed By:
0. -
Roche Only
7. Other
RG6013 emicizumab
Mild to moderate hemophilia A, patients without FVIII inhibitors
2. Phase 3
2022

Description/Summary:

Emicizumab (RG6013, ACE910) is a bispecific antibody that mimics coagulation factor VIII, an essential blood clotting protein. It is being investigated as a therapy for people with mild ot moderate hemophilia A, a congenital bleeding disorder that is caused by deficiency or dysfunction of coagulation factor VIII.

Managed By:
1. Roche Group
Partner:
Chugai

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Phase 1
Phase 2
Phase 3
Filed
Approved
00

New / Advanced

 
 

RG6189

Solid tumors

Solid tumors

 
 

RG6058-10

neoadjuvant and adjuvant non-squamous NSCLC

neoadjuvant and adjuvant non-squamous non-small cell lung cancer (NSCLC) in combination with Tecentriq

 
 

RG6139

solid tumors

solid tumors

 
 

RG7769

solid tumors

solid tumors

 
 

RG7446-42

Tecentriq

ctDNA+ high risk muscle-invasive bladder cancer

ctDNA+ high risk muscle-invasive bladder cancer

 
 

RG3502-10

Kadcyla

adjuvant HER2-positive breast cancer high risk

high risk patients with adjuvant HER2-positive breast cancer in combination with Tecentriq

 
 

RG7446

Tecentriq

adjuvant NSCLC

adjuvant non-small cell lung cancer

 
 

RG7446

Tecentriq

adjuvant NSCLC

adjuvant non-small cell lung cancer

 
 

RG7446

Tecentriq

first line non-squamous and squamous non-small cell lung cancer, PDL1-selected patients

first line non-squamous and squamous non-small cell lung cancer, PDL1-selected patients

 
 

RG7601

Venclexta/Venclyxto

first line acute myeloid leukemia

first line acute myeloid leukemia in combination with azacitidine

 
 

RG7835

autoimmune diseases

autoimmune diseases

 
 

RG7159-7

Gazyva/Gazyvaro

membranous Nephropathy

membranous Nephropathy

 
 

RG6321-3

AMD - 36 week refill interval

age-related macular -36 week refill interval

 
 

RG7716

DME

diabetic macular edema

 
 

RG7716

DME

diabetic macular edema

 
 

RG7716

wAMD

neovascular age related macular degeneration

 
 

RG7716

wAMD

neovascular age related macular degeneration

 
 

RG6422

Adult non-hospitalised SARS-COV-2

Adult non-hospitalised SARS-COV-2

 
 

RG6338

metabolic diseases

metabolic diseases

 
 

RG6168

Enspryng

neuromyelitis optica spectrum disorder

neuromyelitis optica spectrum disorder

00

Removed

 
 

RG6296

r/r multiple myeloma

relapsed/refractory multiple myeloma

 
 

RG7876

solid tumors, combination with vanucizumab or Avastin

solid tumors, combination with vanucizumab or Avastin

 
 

RG7601

Venclexta/Venclyxto

second line or later HR-positive breast cancer

second line or later HR-positive breast cancer

 
 

RG7440

first line HR-positive mBC in combination with palbociclib and fulvestrant

first line HR-positive metastatic breast cancer in combination with palbociclib and fulvestrant

 
 

RG6247

choroideremia

choroideremia

 
 

CHU

hyperphosphatemia

hyperphosphatemia

 
Oncology
 
Immunology
 
Ophthalmology
 
Infectious Diseases
 
CardioMetabolism
 
Neuroscience
 
Other
Area
Product name
Description
Market

Instruments/devices planned for 2021

Core Lab
cobas® pure integrated solutions
Low-to-medium volume SWA
CE
cobas® pro integrated solutions
New high throughput configurations of the cobas pro instrument
CE
Point of Care
cobas® pulse
Successor of Accu-Chek® Inform II
CE
Molecular Lab
cobas® 5800
Fully automated low throughput PCR system
CE
AVENIO Edge System
Automated sequencing library preparation and target enrichment instrument
WW
Diabetes Care
Accu-Chek Instant Forward
New features for the Instant meter to increase performance and user experience
WW

Digital Solutions planned for 2021

Pathology Lab
uPath 2.0
First IVD release and version of Open API of the clinical pathologist workflow module for NAVIFY Digital Pathology & on-premise uPath
WW
RUO Algorithms
Whole slide image analysis algorithms (ER (SP1), Ki-67 (30-9), and PR (1E2))
WW
Insights
NAVIFY Oncology 1.0
Modular Oncology decision support solution
WW3
NAVIFY Pass 1.0
Solution for providers to communicate SARS-CoV-2 rapid antigen test results to a mobile app
US & CE3
Core Lab
Elecsys® GAAD Algorithm
Algorithm for early detection of HCC in patients with chronic liver disease
CE
Diabetes Care
Remote Patient Monitoring
Module within RDCP that enables remote Health Care Professional - Patient with Diabetes interaction, including a patient dashboard, check-in and chat functionality
WW3
Accu-Chek SugarView
Meter-free blood glucose testing using a smartphone and app
OUS3

Tests planned for 2021

Core Lab
Elecsys® SARS-CoV-2 Antigen
Automated laboratory assay intended as an aid in the diagnosis of SARS-CoV-2 infection
US
Elecsys® NT-proBNP IU
A set of 5 intended use extensions in the Coronary Arterial Disease, Atrial Fibrillation and Heart Failure Space
CE
Elecsys® TnT–hs 3 claim extensions in Coronary Arterial Disease
A set of 5 intended use extensions in the Coronary Arterial Disease, Atrial Fibrillation and Heart Failure Space
CE
Molecular Lab
AVENIO FoundationOne kit (RUO)
Decentralized kit of the FoundationOne test
WW
KAPA HyperPETE kit
New targeted sequencing portfolio using primer extension for small targets
WW

Instruments/devices planned for 2020

Diabetes Care
Accu-Chek Solo Diabetes Manager
Integration of the Accu-Chek Guide test strip technology into the Accu-Chek Solo Diabetes Manager (remote control)
CE
Infectious Diseases
cobas® EBV EBNA IgG
EBV panel offering 3 different assays (EBV IgM, EBV VCA IgG, and EBV EBNA IgG) for the qualitative detection of antibodies to Epstein-Barr Virus (EBV)
CE
cobas® EBV VCA IgG
EBV panel offering 3 different assays (EBV IgM, EBV VCA IgG, and EBV EBNA IgG) for the qualitative detection of antibodies to Epstein-Barr Virus (EBV)
CE
cobas® EBV IgM
EBV panel offering 3 different assays (EBV IgM, EBV VCA IgG, and EBV EBNA IgG) for the qualitative detection of antibodies to Epstein-Barr Virus (EBV)
CE
cobas® HIV-1&2 Qual
Qualitative detection and confirmation of HIV-1 & HIV-2
US
cobas® EBV
Monitoring tests for transplant patients to aid in the management of EBV and BKV infections
US
cobas® BKV
Monitoring tests for transplant patients to aid in the management of EBV and BKV infections
US
Cervical Cancer
cobas® HPV (6800/8800)
The world’s leading cobas® HPV assay for use on the fully automated cobas® 6800/8800 Systems
US
CINtec PLUS Cytology
Next generation “Pap” test which leverages p16/Ki-67 dual-stain biomarker technology on cervical cytology samples
US
Tissue Dx
VENTANA HER2 Dual ISH
Fully automated, brightfield ISH assay to determine eligibility for HER2 targeted therapy
US
Algorithm - HER2 (4B5)
Whole slide image analysis algorithm for HER2 (4B5)
CE

Area
Market

WW - Worldwide.
EU - European Union.
US - United States.
* - Achieve commercial readiness, dependent on Pharma label and approval.